Venaxis files for FDA authorization of appendicitis test

|By:, SA News Editor

Venaxis (APPY +1.6%) has filed for FDA 510(k) approval of its APPY1 Test for identifying patients who are at low risk of appendicitis.

The submission comes after APPY1 performed well in a pivotal trial, with sensitivity and negative predictive value results surpassing those in a pilot study. (PR)